Post Operative Pain ManagementNCT06977009
Influence of Occlusal Reduction on Endodontic Postoperative Pain
A study testing Occlusal Reduction in people with Post Operative Pain Management, run by University of Jordan at 1 site in Jordan.
Trial summary
This study aims to assess the impact of occlusal reduction on post-operative pain after single-visit root canal treatment in patients with necrotic pulps or previously initiated (accessed). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Operative Pain Management
- What is being tested?
- Occlusal Reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 28 Feb 2025to 20 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy subjects (ASA I\&II) between the age of 18 and 70 years
- Patients diagnosed with necrotic pulp or previously initiated (accessed).
- Posterior maxillary or mandibular molar tooth.
- Presence of an opposing tooth (or teeth) with normal occlusal contact with the opposing tooth (or teeth).
- Tooth needs cuspal coverage.
Who cannot join
- Pregnant females.
- Patients with significant medical conditions (ASA III \& IV).
- Reported bruxism or clenching.
- Took analgesics\antibiotics or other drugs that might alter their pain during the last 12 hours preoperatively.
- A history of allergic reactions to any of the medications and/or materials used.
- Patients with a tooth that had no contacts or premature contact, fewer than three teeth on one side of the jaw.
- Greater than grade I mobility or pocket depth greater than 5mm.
- Non-restorable crowns, severely curved root canals, or post-treatment endodontic disease were, also, excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Jordan university hospital
Amman, Amman Governorate, 11185
Jordan University Hospital, +96265353444, juhosp@ju.edu.jo
Abdulrahman Mwaffaq Kahhaleh, Masters student
About this study
Official title: Influence of Occlusal Reduction on Endodontic Postoperative Pain: a Randomized Clinical Trial
This study aims to assess the impact of occlusal reduction on post-operative pain after single-visit root canal treatment in patients with necrotic pulps or previously initiated (accessed).
Read the detailed description
A randomized clinical trial will take place at the postgraduate endodontic clinic department at JU Hospital to assess the effect of occlusal reduction on post-operative pain. Participants will be enrolled from the pool of patients referred to the department of endodontics at JUH for root canal treatment, and the trial will be carried out on those diagnosed with necrotic pulps or previously initiated (accessed) teeth.
Patients will undergo root canal treatment by postgraduate students, under rubber dam, and using the dental operating microscope.
At the completion of endodontic treatment, the numbered, sealed, randomization envelope will be opened by the operator, and patient allocation will be revealed.
Access cavity will be sealed with Glass ionomer restoration, then patients will be allocated to either undergo occlusal reduction (Intervention group) where all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges will be reduced using a diamond bur, or not undergo occlusal reduction (Control group) where all occlusal contacts will remain intact.
The presence or absence of contact will be confirmed using articulating paper where occlusal surfaces will be dried and articulating paper will be held between the teeth with the mandible guided to the centric position. Intact occlusion will be assessed by examining the marks on the teeth.
A high-speed handpiece with copious coolant will be used to remove occlusal contacts (Intervention group) or just moved above the surface of the tooth without contacting the occlusal surface (Control group) to facilitate patient blinding.
The patient will be told to not change his or her restoration to a permanent restoration for at least a week (before the completion of data collection).
Treatment will be completed in a single visit.
Pain will be assessed according to a visual analog scale (VAS). Scores will be taken before commencing the procedure (pre-operative pain) and after the treatment at different time intervals; 6, 24, 48 hours, and 1 week after. This will be done by calling the patients by phone to record the degree of pain at these intervals.
The assessment of postoperative pain will be performed by a researcher-examiner blinded to the carried-out treatments.
- Conditions
- Post Operative Pain Management
- Being tested
- Occlusal Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal ReductionProcedure or surgery
patients will be allocated to either undergo occlusal reduction (Intervention group) where all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges will be reduced using a diamond bur, or not undergo occlusal reduction (Control group) where all occlusal contacts will remain intact.
The presence or absence of contact will be confirmed using articulating paper where occlusal surfaces will be dried and articulating paper will be held between the teeth with the mandible guided to the centric position. Intact occlusion will be assessed by examining the marks on the teeth.
A high-speed handpiece with copious coolant will be used to remove occlusal contacts (Intervention group) or just moved above the surface of the tooth without contacting the occlusal surface (Control group) to facilitate patient blinding.
| Study group | Role | What they receive |
|---|---|---|
| occlusal reduction (Intervention group) | Active comparator | all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges will be reduced using a diamond bur. Receives: Procedure: Occlusal Reduction |
| no occlusal reduction (Control group) | No intervention | all occlusal contacts will remain intact. |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of occlusal reduction on post-operative pain after single-visit root canal treatment by using the visual analog scale (VAS).
to assess the impact of occlusal reduction on post-operative pain after single-visit root canal treatment in patients with necrotic pulps or previously initiated (accessed) by using visual analog scale (VAS) at 6, 24, 48 hours, and 1 week following the treatment.
The VAS consists of a 10-cm line anchored by two extremes "No pain" and "pain as bad as could be". The patients were asked to choose the mark that represented their level of pain. Pain level was assigned to one of four categorical groups: None (0); Mild (1-3); Moderate (4- 6); Severe (7-10). The scale was explained visually, verbally and numerically to facilitate its use by the participants.
This will be done by calling the patients by phone to record the degree of pain at these intervals as explained in the study description.
Measured: from the enrollment of the patient up to 1 week for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start28 Feb 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical trial will take place at the postgraduate endodontic clinic department at JU Hospital to assess the effect of occlusal reduction on post-operative pain. Participants will be enrolled from the pool of patients referred to the department of endodontics at JUH for root canal treatment, and the trial will be carried out on those diagnosed with necrotic pulps or previously initiated (accessed) teeth.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Mwaffaq Kahhaleh, University of Jordan
- Investigators
- Mohammad Hammad, Associate Professor, Study director, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977009
- Sponsor's protocol ID
- occlusal reduction after RCT
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shamszadeh S, Shirvani A, Asgary S. Does occlusal reduction reduce post-endodontic pain? A systematic review and meta-analysis. J Oral Rehabil. 2020 Apr;47(4):528-535. doi: 10.1111/joor.12929. Epub 2020 Jan 16.
PubMed 31880822Nguyen-Nhon D, Nagendrababu V, Pulikkotil SJ, Rossi-Fedele G. Effect of occlusal reduction on postendodontic pain: A systematic review and meta-analysis of randomised clinical trials. Aust Endod J. 2020 Aug;46(2):282-294. doi: 10.1111/aej.12380. Epub 2019 Oct 22.
PubMed 31638301Parirokh M, Rekabi AR, Ashouri R, Nakhaee N, Abbott PV, Gorjestani H. Effect of occlusal reduction on postoperative pain in teeth with irreversible pulpitis and mild tenderness to percussion. J Endod. 2013 Jan;39(1):1-5. doi: 10.1016/j.joen.2012.08.008. Epub 2012 Sep 29.
PubMed 23228248
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Occlusal Reduction on Endodontic Postoperative Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06977009
- Acronym / sponsor ID
- occlusal reduction after RCT
- Conditions
- Post Operative Pain Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the impact of occlusal reduction on post-operative pain after single-visit root canal treatment in patients with necrotic pulps or previously initiated (accessed).
Detailed description
A randomized clinical trial will take place at the postgraduate endodontic clinic department at JU Hospital to assess the effect of occlusal reduction on post-operative pain. Participants will be enrolled from the pool of patients referred to the department of endodontics at JUH for root canal treatment, and the trial will be carried out on those diagnosed with necrotic pulps or previously initiated (accessed) teeth.
Patients will undergo root canal treatment by postgraduate students, under rubber dam, and using the dental operating microscope.
At the completion of endodontic treatment, the numbered, sealed, randomization envelope will be opened by the operator, and patient allocation will be revealed.
Access cavity will be sealed with Glass ionomer restoration, then patients will be allocated to either undergo occlusal reduction (Intervention group) where all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges will be reduced using a diamond bur, or not undergo occlusal reduction (Control group) where all occlusal contacts will remain intact.
The presence or absence of contact will be confirmed using articulating paper where occlusal surfaces will be dried and articulating paper will be held between the teeth with the mandible guided to the centric position. Intact occlusion will be assessed by examining the marks on the teeth.
A high-speed handpiece with copious coolant will be used to remove occlusal contacts (Intervention group) or just moved above the surface of the tooth without contacting the occlusal surface (Control group) to facilitate patient blinding.
The patient will be told to not change his or her restoration to a permanent restoration for at least a week (before the completion of data collection).
Treatment will be completed in a single visit.
Pain will be assessed according to a visual analog scale (VAS). Scores will be taken before commencing the procedure (pre-operative pain) and after the treatment at different time intervals; 6, 24, 48 hours, and 1 week after. This will be done by calling the patients by phone to record the degree of pain at these intervals.
The assessment of postoperative pain will be performed by a researcher-examiner blinded to the carried-out treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized clinical trial will take place at the postgraduate endodontic clinic department at JU Hospital to assess the effect of occlusal reduction on post-operative pain. Participants will be enrolled from the pool of patients referred to the department of endodontics at JUH for root canal treatment, and the trial will be carried out on those diagnosed with necrotic pulps or previously initiated (accessed) teeth.
| Arm | Type | Receives |
|---|---|---|
| occlusal reduction (Intervention group) | Active comparator | Procedure: Occlusal Reductionall occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges will be reduced using a diamond bur. |
| no occlusal reduction (Control group) | No intervention | –all occlusal contacts will remain intact. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy subjects (ASA I\&II) between the age of 18 and 70 years
- Patients diagnosed with necrotic pulp or previously initiated (accessed).
- Posterior maxillary or mandibular molar tooth.
- Presence of an opposing tooth (or teeth) with normal occlusal contact with the opposing tooth (or teeth).
- Tooth needs cuspal coverage.
Key exclusion criteria (8 listed)
- Pregnant females.
- Patients with significant medical conditions (ASA III \& IV).
- Reported bruxism or clenching.
- Took analgesics\antibiotics or other drugs that might alter their pain during the last 12 hours preoperatively.
- A history of allergic reactions to any of the medications and/or materials used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusal Reductionpatients will be allocated to either undergo occlusal reduction (Intervention group) where all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges will be reduced using a diamond bur, or not undergo occlusal reduction (Control group) where all occlusal contacts will remain intact. The presence or absence of contact will be confirmed using articulating paper where occlusal surfaces will be dried and articulating paper will be held between the teeth with the mandible guided to the centric position. Intact occlusion will be assessed by examining the marks on the teeth. A high-speed handpiece with copious coolant will be used to remove occlusal contacts (Intervention group) or just moved above the surface of the tooth without contacting the occlusal surface (Control group) to facilitate patient blinding. | Procedure or surgery | occlusal reduction (Intervention group) |
Primary outcome
impact of occlusal reduction on post-operative pain after single-visit root canal treatment by using the visual analog scale (VAS).
Time frame: from the enrollment of the patient up to 1 week for each patient
to assess the impact of occlusal reduction on post-operative pain after single-visit root canal treatment in patients with necrotic pulps or previously initiated (accessed) by using visual analog scale (VAS) at 6, 24, 48 hours, and 1 week following the treatment. The VAS consists of a 10-cm line anchored by two extremes "No pain" and "pain as bad as could be". The patients were asked to choose the mark that represented their level of pain. Pain level was assigned to one of four categorical groups: None (0); Mild (1-3); Moderate (4- 6); Severe (7-10). The scale was explained visually, verbally and numerically to facilitate its use by the participants. This will be done by calling the patients by phone to record the degree of pain at these intervals as explained in the study description.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Results publication: PubMed 31880822Shamszadeh S, Shirvani A, Asgary S. Does occlusal reduction reduce post-endodontic pain? A systematic review and meta-analysis. J Oral Rehabil. 2020 Apr;47(4):528-535. doi: 10.1111/joor.12929. Epub 2020 Jan 16.
- Results publication: PubMed 31638301Nguyen-Nhon D, Nagendrababu V, Pulikkotil SJ, Rossi-Fedele G. Effect of occlusal reduction on postendodontic pain: A systematic review and meta-analysis of randomised clinical trials. Aust Endod J. 2020 Aug;46(2):282-294. doi: 10.1111/aej.12380. Epub 2019 Oct 22.
- Results publication: PubMed 23228248Parirokh M, Rekabi AR, Ashouri R, Nakhaee N, Abbott PV, Gorjestani H. Effect of occlusal reduction on postoperative pain in teeth with irreversible pulpitis and mild tenderness to percussion. J Endod. 2013 Jan;39(1):1-5. doi: 10.1016/j.joen.2012.08.008. Epub 2012 Sep 29.
- Effect of Occlusal Adjustment on Postoperative Pain after Root Canal Treatment: A Randomized Clinical TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad Hammad, Associate Professor study director
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusal Reduction in people with Post Operative Pain Management, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdulrahman Mwaffaq Kahhaleh, Masters student (00962795051676, abd_k97@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of occlusal reduction on post-operative pain after single-visit root canal treatment by using the visual analog scale (VAS). (time frame: from the enrollment of the patient up to 1 week for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06977009, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.